Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-04 @ 11:36 PM
Study NCT ID:
NCT03150550
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mindfulness
Brief Summary:
Among behavioral cognitive psychotherapies, new "Mindfulness" interventions allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. This "to do with" training has yielded promising results in stress management, prevention of depressive relapse, management of craving and an increase in self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this technique on alcohol relapse, in particular by comparing it with a usual management strategy (conventional relapse prevention therapy).
The main objective of this study is to compare the efficacy on alcoholic relapse (measured in the "first glass" consumed), from a Mindfulness therapeutic program to a conventional Relapse Prevention program. Secondary objectives are to demonstrate the efficacy of this program on craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of alcoholisation days).
The main objective of this study is to compare the efficacy on alcoholic relapse (measured in the "first glass" consumed), from a Mindfulness therapeutic program to a conventional Relapse Prevention program. Secondary objectives are to demonstrate the efficacy of this program on craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of alcoholisation days).
Detailed Description:
Each patient will perform 12 psychotherapeutic sessions (Mindfulness or Relapse Prevention) over a period of 6 weeks. Patients will be evaluated by a practitioner different from the practitioner who makes the psychotherapeutic management.
Patients will be assessed at inclusion (Initial visit), after the 12 sessions of management (M0), 1 month (M1), 2 month (M2), 3 month (M3), 4 month (M4), 5 month (M5), 6 month (M6), after initial visit as follows
Initial Visit
* Signature of an informed consent form.
* Demographic characteristics (gender, age, family status, professional status, level of education …)
* Clinical data (patient status, ongoing pharmacological treatment, withdrawal, previous CBT ...)
* Criteria and severity of alcohol dependence (DSM 5)
* Evaluation of depressive symptomatology and severity (HAM-D)
* Level of pre-intervention alcohol consumption (AUDIT-C)
* "Binge drinking" consumption
* Craving before alcohol withdrawal (EVA craving)
* Mindfulness Skills (KIMS)
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Drinking habits (QHPBA)
After the 12 sessions (M0)
* Data on treatments in progress or change in treatment
* Depressive symptomatology and severity (HAM-D)
* Level of alcohol consumption in post-intervention (AUDIT-C)
* "Binge drinking" consumption
* Craving after alcohol withdrawal (EVA craving)
* Mindfulness Skills (KIMS)
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 1st Daily Alcohol Logbook (TLFB)
At 1 month (M1)
* Return of the 1st Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 2nd Daily Alcohol Logbook (TLFB)
At 2 month (M2)
* Return of the 2nd Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 3th Daily Alcohol Logbook (TLFB)
At 3 month (M3)
* Return of the 3th Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 4th Daily Alcohol Logbook (TLFB)
At 4 month (M4)
* Return of the 4th Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 5th Daily Alcohol Logbook (TLFB)
At 5 month (M5)
* Return of the 5th Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 6th Daily Alcohol Logbook (TLFB)
At 6 month (M6)
* Return of the 6th Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
Patients will be assessed at inclusion (Initial visit), after the 12 sessions of management (M0), 1 month (M1), 2 month (M2), 3 month (M3), 4 month (M4), 5 month (M5), 6 month (M6), after initial visit as follows
Initial Visit
* Signature of an informed consent form.
* Demographic characteristics (gender, age, family status, professional status, level of education …)
* Clinical data (patient status, ongoing pharmacological treatment, withdrawal, previous CBT ...)
* Criteria and severity of alcohol dependence (DSM 5)
* Evaluation of depressive symptomatology and severity (HAM-D)
* Level of pre-intervention alcohol consumption (AUDIT-C)
* "Binge drinking" consumption
* Craving before alcohol withdrawal (EVA craving)
* Mindfulness Skills (KIMS)
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Drinking habits (QHPBA)
After the 12 sessions (M0)
* Data on treatments in progress or change in treatment
* Depressive symptomatology and severity (HAM-D)
* Level of alcohol consumption in post-intervention (AUDIT-C)
* "Binge drinking" consumption
* Craving after alcohol withdrawal (EVA craving)
* Mindfulness Skills (KIMS)
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 1st Daily Alcohol Logbook (TLFB)
At 1 month (M1)
* Return of the 1st Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 2nd Daily Alcohol Logbook (TLFB)
At 2 month (M2)
* Return of the 2nd Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 3th Daily Alcohol Logbook (TLFB)
At 3 month (M3)
* Return of the 3th Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 4th Daily Alcohol Logbook (TLFB)
At 4 month (M4)
* Return of the 4th Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 5th Daily Alcohol Logbook (TLFB)
At 5 month (M5)
* Return of the 5th Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
* Distribution of the 6th Daily Alcohol Logbook (TLFB)
At 6 month (M6)
* Return of the 6th Daily Alcohol Logbook (TLFB)
* Data on treatments in progress or change in treatment
* Mindfulness Skills (KIMS)
* "Binge drinking" consumption
* Self-efficacy to remain abstinent (QAE-Alcohol)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-A00048-43 | OTHER | 2016-A00048-43 | View |